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Vitamin D Supplementation After Parathyroid Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00982722
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Inga-Lena Nilsson, Karolinska University Hospital

Brief Summary:
A randomised double blind clinical trial, accepted by the Medical Products Agency and registered in the European Clinical Trials Database. Aims to evaluate the prevalence of vitamin D deficiency in a pHPT population in relation to gender and age, the correlation between vitamin D status, pre- and postoperative parathyroid hormone level and bone density and the correlation between vitamin D status, metabolic, cardiovascular risk factors and QoL aspects before and after parathyroid adenomectomy.

Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Drug: cholecalciferol and calcium carbonate Drug: calcium carbonate Not Applicable

Detailed Description:
150 PHPT patients were randomized six weeks after surgery, 75 into each group, to 1 year of oral treatment with either calcium carbonate 1 g (500 mg twice daily) alone or calcium carbonate 1 g combined with cholecalciferol 1600 IU (800 IU twice daily). Exclusion criteria were age under 18, manifest osteoporosis at PHPTdiagnosis, persistent hypercalcemia after surgery, postoperative hypocalcemia requiring vitamin D treatment, glomerular filtration rate (GFR) below 40 ml/min, pregnancy, breast feeding, or logistical difficulties, for example living far from the hospital. Included patients had to withdraw any current supplementation with calcium and vitamin D during the study period. All tablets were identical in appearance, the tins were numbered and randomization followed a list compiled by an independent clinical research support organization. The time for randomization was chosen to make sure that the PHPT patients were cured before starting the study medication. Nearly three-quarters of the patients were randomized within 6 weeks after PTX.The primary end point was the change in PTH after PTX and treatment with the study medication. Secondary end points were vitamin D levels, insulin resistance, blood pressure and other cardiovascular risk factors, biochemical markers of bone turnover, bone mineral density and self estimated health related quality of life (SF- 36).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism
Study Start Date : April 2008
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 4, 2018


Arm Intervention/treatment
Experimental: cholecalciferol and calcium carbonate
cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2
Drug: calcium carbonate
calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery
Other Name: cholecalciferol and calcium carbonate

Active Comparator: calciumcarbonate
calcium carbonate 500 mg x 2
Drug: cholecalciferol and calcium carbonate
cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery
Other Name: calcium carbonate




Primary Outcome Measures :
  1. postoperative parathyroid hormone level [ Time Frame: 3 months ]
    PTH

  2. ambulatory blood pressure [ Time Frame: one year ]
    24h blood pressure


Secondary Outcome Measures :
  1. bone mineral density [ Time Frame: one year ]
    DEXA

  2. 25-OH Vitamin D [ Time Frame: 3 months ]
    s-25OHD

  3. Calcium [ Time Frame: 6 weeks ]
    ionized calcium

  4. Quality of life-self estimating formularies [ Time Frame: one year ]
    SF36



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion Criteria:

  • Renal insufficiency
  • Severe osteoporosis
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982722


Locations
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Sweden
Karolinska UH
Stockholm, Sweden, 17176
Karolinska University Hospital
Stockholm, Sweden, SE-17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Inga-Lena Nilsson, MD, Ass prof Karolinska UH

Publications of Results:
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Responsible Party: Inga-Lena Nilsson, Assoc prof, senior consultant, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00982722    
Other Study ID Numbers: Eudra CT 2007-003691-19
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Inga-Lena Nilsson, Karolinska University Hospital:
primary hyperparathyroidism
postoperative vitamin D supplementation
Additional relevant MeSH terms:
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Calcium, Dietary
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Parathyroid Hormone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents